Trial Outcomes & Findings for Buoy Electrolyte Study on Hydration Status of Active Men and Women (NCT NCT05768789)
NCT ID: NCT05768789
Last Updated: 2025-05-14
Results Overview
Determined by subtracting the cumulative urine output from the total fluid load consumed
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
360 minutes after ingestion
Results posted on
2025-05-14
Participant Flow
All enrolled participants completed 3 separate visits in a crossover design, each visit consisting of a different intervention. All participants completed the visits and interventions in the same order as listed below.
Participant milestones
| Measure |
Buoy Electrolyte Then Water Only Then Nuun Electrolyte
Visit 1 - Buoy Electrolyte: Buoy intervention amount is 4% of total body weight given in 16 divided doses over 4 hours. The goal is to give 600mg of Na+ over 4 hours while measuring urine output over 6 hours. Therefore, to safely achieve a total dose 600mg Na+ (6-fold increase from single dose) we will use 4 tsps (18 ml) of Buoy diluted in 1 L of water.
Visit 2 - Water Alone: Water serves as a control. Participants will ingest the same quantity of water (1 L) at a rate of 6.25% of the calculated amount of water every 15 min for 4 hours.
Visit 3 - Nuun Electrolyte Tablet: Nuun intervention given as 1L bolus and then free water in divided doses for a total of 4% total body weight. The goal is to give a one-time dose of Nuun (600mg Na+) at the start of the trial, diluted in 1L water to be consumed within 30 min (similar to prior published data, Pence 2020).
|
|---|---|
|
Visit 1 : Buoy Electrolyte
STARTED
|
30
|
|
Visit 1 : Buoy Electrolyte
COMPLETED
|
30
|
|
Visit 1 : Buoy Electrolyte
NOT COMPLETED
|
0
|
|
Visit 2: Water Only
STARTED
|
30
|
|
Visit 2: Water Only
COMPLETED
|
30
|
|
Visit 2: Water Only
NOT COMPLETED
|
0
|
|
Visit 3: Nuun Electrolyte
STARTED
|
30
|
|
Visit 3: Nuun Electrolyte
COMPLETED
|
30
|
|
Visit 3: Nuun Electrolyte
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Enrolled Participants
n=30 Participants
All enrolled participants completed 3 separate visits, each visit consisting of a different intervention. All participants completed the visits and interventions in the same order as listed below.
Visit 1 - Buoy Electrolyte: Buoy intervention amount is 4% of total body weight given in 16 divided doses over 4 hours. The goal is to give 600mg of Na+ over 4 hours while measuring urine output over 6 hours. The recommended Buoy dosage is ⅓ tsp in 237 ml of water (50mg Na+) multiple times a day (Table 1). Therefore, to safely achieve a total dose 600mg Na+ (6-fold increase from single dose) we will use 4 tsps (18 ml) of Buoy diluted in 1 L of water.
Visit 2 - Water Alone: Water serves as a control. Participants will ingest the same quantity of water (1 L) at a rate of 6.25% of the calculated amount of water every 15 min for 4 hours.
Visit 3 - Nuun Electrolyte Tablet: Nuun intervention given as 1L bolus and then free water in divided doses for a total of 4% total body weight. The goal is to give a one-time dose of Nuun (600mg Na+) at the start of the trial, diluted in 1L water to be consumed within 30 min (similar to prior published data, Pence 2020).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=30 Participants
|
|
Age, Continuous
|
29.9 Years
STANDARD_DEVIATION 5.6 • n=30 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=30 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=30 Participants
|
|
Body Weight (kg)
|
82.6 kilograms
STANDARD_DEVIATION 16.9 • n=30 Participants
|
|
Body Mass Index (BMI)
|
27.7 kg/m^2
STANDARD_DEVIATION 6.1 • n=30 Participants
|
PRIMARY outcome
Timeframe: 360 minutes after ingestionDetermined by subtracting the cumulative urine output from the total fluid load consumed
Outcome measures
| Measure |
Buoy Hydration Drops
n=30 Participants
Visit 1 consisted of the Buoy Hydration Drops beverage intervention at a dose containing 600mg/Litre of Na+ over 4 hours. All 30 participants completed visit 1.
|
Water Alone - Control
n=30 Participants
Visit 2 consisted of water alone as a control in which each subject ingested 1L of water at a rate of 6/25% of the calculated amount of water every 15 minutes for 4 hours. All 30 participants completed visit 2.
|
Nuun Sport Hydration Tabs
n=30 Participants
Visit 3 consisted of the Nunn Sport Hydration Tabs in which each subject consumed 1L of water with two dissolved tabs, containing 600mg of Na+ over 30 minutes. All 30 participants completed visit 3.
|
|---|---|---|---|
|
Net Fluid Balance
|
0.28 Liter
Standard Deviation 0.28
|
0.05 Liter
Standard Deviation 0.32
|
0.03 Liter
Standard Deviation 0.20
|
PRIMARY outcome
Timeframe: Urine will be measured during each visit (three total visits that each last 6 hours)Sodium levels will be measured
Outcome measures
| Measure |
Buoy Hydration Drops
n=30 Participants
Visit 1 consisted of the Buoy Hydration Drops beverage intervention at a dose containing 600mg/Litre of Na+ over 4 hours. All 30 participants completed visit 1.
|
Water Alone - Control
n=30 Participants
Visit 2 consisted of water alone as a control in which each subject ingested 1L of water at a rate of 6/25% of the calculated amount of water every 15 minutes for 4 hours. All 30 participants completed visit 2.
|
Nuun Sport Hydration Tabs
n=30 Participants
Visit 3 consisted of the Nunn Sport Hydration Tabs in which each subject consumed 1L of water with two dissolved tabs, containing 600mg of Na+ over 30 minutes. All 30 participants completed visit 3.
|
|---|---|---|---|
|
Electrolytes in Urine
|
39 milliequivalent/L (meq/L)
Standard Deviation 15
|
58 milliequivalent/L (meq/L)
Standard Deviation 21
|
48 milliequivalent/L (meq/L)
Standard Deviation 47
|
PRIMARY outcome
Timeframe: 360 minutes after ingestionOsmolarity measures the concentration of solutes in urine. This is a key indicator of how concentrated or diluted the urine is, which directly reflects hydration status and kidney function. This can fluctuate depending on how much water the kidneys are excreting or retaining.
Outcome measures
| Measure |
Buoy Hydration Drops
n=30 Participants
Visit 1 consisted of the Buoy Hydration Drops beverage intervention at a dose containing 600mg/Litre of Na+ over 4 hours. All 30 participants completed visit 1.
|
Water Alone - Control
n=30 Participants
Visit 2 consisted of water alone as a control in which each subject ingested 1L of water at a rate of 6/25% of the calculated amount of water every 15 minutes for 4 hours. All 30 participants completed visit 2.
|
Nuun Sport Hydration Tabs
n=30 Participants
Visit 3 consisted of the Nunn Sport Hydration Tabs in which each subject consumed 1L of water with two dissolved tabs, containing 600mg of Na+ over 30 minutes. All 30 participants completed visit 3.
|
|---|---|---|---|
|
Urine Osmolarity (mOsm/kg)
|
1928 milliOsm/kilogram (mOsm/kg)
Standard Deviation 544
|
1666 milliOsm/kilogram (mOsm/kg)
Standard Deviation 454
|
1866 milliOsm/kilogram (mOsm/kg)
Standard Deviation 318
|
SECONDARY outcome
Timeframe: 360-minutes after ingestionBio impedance measured through difference in body fat % pre- and post-urine
Outcome measures
| Measure |
Buoy Hydration Drops
n=30 Participants
Visit 1 consisted of the Buoy Hydration Drops beverage intervention at a dose containing 600mg/Litre of Na+ over 4 hours. All 30 participants completed visit 1.
|
Water Alone - Control
n=30 Participants
Visit 2 consisted of water alone as a control in which each subject ingested 1L of water at a rate of 6/25% of the calculated amount of water every 15 minutes for 4 hours. All 30 participants completed visit 2.
|
Nuun Sport Hydration Tabs
n=30 Participants
Visit 3 consisted of the Nunn Sport Hydration Tabs in which each subject consumed 1L of water with two dissolved tabs, containing 600mg of Na+ over 30 minutes. All 30 participants completed visit 3.
|
|---|---|---|---|
|
Bio Impedance
|
0.75 percentage of body fat difference
Standard Deviation 0.62
|
0.64 percentage of body fat difference
Standard Deviation 0.65
|
0.44 percentage of body fat difference
Standard Deviation 0.32
|
Adverse Events
Buoy Hydration Drops
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Water Alone - Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nuun Sport Hydration Tabs
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Harikesh Subramanian, MBBS, MS, D.ABA, ABPM-CI
University of Pittsburgh, UPMC
Phone: 412-647-9085
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place